A Randomized Multicenter Phase III Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer.
Overview
- Phase
- Phase 3
- Intervention
- cetuximab
- Conditions
- Locally Advanced Head and Neck Cancer
- Sponsor
- Lund University Hospital
- Enrollment
- 298
- Locations
- 9
- Primary Endpoint
- Overall survival
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The primary endpoint in this study is to investigate if there is a difference in overall survival in patients with locally advanced head and neck cancer, randomized to either radiotherapy and cetuximab or radiotherapy and cisplatin. A second randomization is performed in patients with T3-T4 tumors; allocated radiotherapy either 68.0 Gy or 73.1 Gy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age at least 18 years
- •Histologically or cytologically confirmed , previous untreated head and neck squamous cell cancer of the oral cavity, hypopharynx, larynx or of the oral cavity aimed for unimodal treatment with radiotherapy with curative intent
- •Tumor stage III and IV , but no evidence of distant metastases beyond the regional nodes in the neck
- •WHO/Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •The patient must be expected to withstand radiotherapy combined with cisplatin or cetuximab
- •The patient must be able to understand the information about the treatment and give a written informed concent to participate in the trial
- •Adequate follow-up study must be possible; this will exclude a patient who is uncooperative
- •Adequate renal function, creatinine clearance over 50 ml/min/1.73 estimated according to local practice at each study centre
Exclusion Criteria
- •Previous malignant disease in the head and neck region, with exception for basal cell carcinoma or curatively treated squamous cell carcinoma of the skin with follow-up time of at least 3 years
- •Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri, or other previous malignancy with a disease-free interval of at least 5 years
- •Two or more synchronous primary head and neck squamous cell cancer at time of diagnosis
- •Co-existing disease prejudicing survival (expected survival less than 6 months)
- •Absolute neutrophil count less than 1.5 x 109/L
- •Platelet count less than 100 x 109/L
- •Bilirubin over 1.5 times upper limit of normal
- •Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) more than 3 times upper limit of normal
- •Pregnancy or lactation
- •Allergy to study drug or to the excipients in their formulation
Arms & Interventions
Arm 1
Radiotherapy with a dose of 68.0 Gy in 34 fractions, and cetuximab with a loading dose of 400 mg/m2 one week before start of radiotherapy, then 250 mg/m2 weekly during radiotherapy (tumor stage 1-4).
Intervention: cetuximab
Arm 1
Radiotherapy with a dose of 68.0 Gy in 34 fractions, and cetuximab with a loading dose of 400 mg/m2 one week before start of radiotherapy, then 250 mg/m2 weekly during radiotherapy (tumor stage 1-4).
Intervention: cisplatin
Arm 2
Radiotherapy with a dose of 73.1 Gy in 34 fractions, and cetuximab with a loading dose of 400 mg/m2 one week before start of radiotherapy, then 250 mg/m2 weekly during radiotherapy (tumor stage 3-4).
Intervention: cetuximab
Arm 2
Radiotherapy with a dose of 73.1 Gy in 34 fractions, and cetuximab with a loading dose of 400 mg/m2 one week before start of radiotherapy, then 250 mg/m2 weekly during radiotherapy (tumor stage 3-4).
Intervention: cisplatin
Arm 3
Radiotherapy with a dose of 68.0 Gy in 34 fractions, and cisplatin weekly with a dose of 40 mg/m2 (tumor stage 1-4).
Intervention: cetuximab
Arm 3
Radiotherapy with a dose of 68.0 Gy in 34 fractions, and cisplatin weekly with a dose of 40 mg/m2 (tumor stage 1-4).
Intervention: cisplatin
Arm 4
Radiotherapy with a dose of 73.1 Gy in 34 fractions, and cisplatin weekly with a dose of 40 mg/m2 (tumor stage 3-4).
Intervention: cetuximab
Arm 4
Radiotherapy with a dose of 73.1 Gy in 34 fractions, and cisplatin weekly with a dose of 40 mg/m2 (tumor stage 3-4).
Intervention: cisplatin
Outcomes
Primary Outcomes
Overall survival
Time Frame: Every 3 month for 2 years, and every 6 month until 5 years for evaluation of overall survival